This invention relates to a medical guidewire and to a means of protecting such guidewires during shipping and handling.
Guidewires are routinely used in medical procedures where it is desired to introduce a catheter into a patient's blood vessel such as an artery or vein.
In a typical procedure, one approach of utilizing such guidewires for the positioning of a catheter is called the Seldinger technique. In that technique, a catheter introducer is used that has a relatively short flexible cannula that is placed within the patient's blood vessel. Actual insertion of the cannula is assisted by the use of a needle that is positioned within the cannula and is thus inserted in the blood vessel. Upon insertion, the needle is withdrawn, leaving the cannula tip within the blood stream vessel and the body of the catheter introducer external of the patient.
A guidewire is then introduced through the catheter introducer and is extended through the tip of the cannula within the patient's blood vessel until it is positioned with its tip at the desired location within the patient. Upon removal of the catheter introducer, the guidewire remains in the patient and a long catheter is easily slid over the guidewire to the desired position and the guidewire withdrawn. Thus, the catheter remains within the patient having its distal end located at the proper position within the patient's blood vessel.
Such guidewires are delivered through normal shipping channels and are subject to considerable handling prior to and during shipment. The guidewire itself is packaged within a protective tube in a coiled form. Generally, a guidewire straightener fits within the end of the protective tube and the guidewire itself passes through the guidewire straightener and has its end formed into a J configuration just outside the distal end of the guidewire straightener.
The purpose of the guidewire straightener is to provide a channel into which the wire is drawn to straighten out the J configuration just prior to introduction into the patient. Since there normally is no restriction or engagement of the guidewire through the guidewire straightener, the guidewire freely moves with respect to the protective tube and the guidewire straightener.
Unfortunately, the fairly unrestricted movement of the guidewire within its protective tube causes problems in its packaging and later handling. One difficulty arises during packaging since the container within which the guidewire is packaged of necessity is subject to sterilization procedures where a sterilizing material, such as ethylene oxide, is allowed to permeate the plastic package to sterilize the guidewire within that package. The plastic material allows the sterilizing material to pass through to carry out sterilization yet is a barrier to the entry of bacteria.
Accordingly, a problem exists in that the guidewire, once inserted in the package can migrate out of its protective tubing even prior to the sterilization procedure, and can extend outside the normally sealed area, such that when the cover is applied, the guidewire actually extends outside and thus prevents sterilization from becoming effective.
As a further difficulty, during shipment, the guidewire can migrate entirely from its protective tube and remain coiled within its package. As that package is opened by a physician for access to the guidewire, the guidewire is thus unrestrained and can spring out of the package and fall to the floor. Again, obviously, sterilization is breached and the guidewire is unuseable.
Further yet, the wire may migrate from the protective tube during transportation and become kinked within its package. Kinking is irreversable damage to a guidewire and may easily render it unuseable.